Z-1100-2022 Class II Terminated
FDA device recall Z-1100-2022 was initiated by Clinician's Choice Dental Products Inc. on March 18, 2022 and is designated Class II. Reason for recall: Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK The recall status is terminated (terminated March 19, 2024). Affected quantity: 46 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2022
- Initiation Date
- March 18, 2022
- Termination Date
- March 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46 units
Product Description
Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912
Reason for Recall
Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK
Distribution Pattern
Distributed in SC.
Code Information
LOT No.: 611612 (UDI): 07540172000178